Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.
• Oversee the execution of Start Up and/or Maintenance for assigned projects in accordance with the agreed RSU strategy.
• Implement and maintain the RSU Management Plan in accordance with the Scope of Work and Project Plan, within the agreed project strategy.
• Ensure collaboration across RSU, including communication with countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
• Assist with creation and/or review of technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
• Provide overall guidance and oversight of multi-site projects during initial start-up and maintenance phase as an integral member of the study management team.
• Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations; identify regulatory complexity and challenges and offer creative and practical solutions to support execution of the RSU plan.
• Contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
• Ensure overall project efficiency and adherence to project timelines and financial goals; report performance metrics and out of scope activities as required.
• Ensure appropriate quality standards (following RSU Management Plan and relevant Work Instructions) for the duration of Start Up (or Maintenance, as applicable).
• Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information.
• May participate in developing long standing relationships with preferred Quintiles customers.
• Support delivery of presentations/training to clients, colleagues and professional bodies, as required.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
• Good negotiation and communication skills with ability to challenge
• Good interpersonal skills, a strong team player
• Good understanding of regulated clinical trial environment and knowledge of drug development process
• Experience in regulatory and/or technical writing
• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
• Ability to exercise independent judgment taking calculated risks when making decisions
• Good leadership skills, with ability to motivate
• Good organizational and planning skills
• Good presentation skills
• Good understanding of study financial management
• Good attention to detail
• Ability to work on multiple projects balancing competing priorities
• Ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree in life sciences or related field, with 3 years' relevant experience including demonstrable experience in a regional role or equivalent combination of education, training and experience.
• Extensive use of keyboard requiring repetitive motion of fingers.
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
• Regular sitting for extended periods of time.
• Potential for frequent travel.
We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™